RegWardenFDA facility compliance records
Facility

Church & Dwight Manufacturing Co., Inc.

3 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2011: 1 recalls; 2013: 1 recalls; 2017: 1 inspections; 2022: 1 inspections; 2023: 1 recalls, 1 inspections; 2024: 1 inspections1’11’121’13’14’15’161’17’18’19’20’211’222’231’24’25’26
  • Recalls (3)
  • Inspections (4)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2023-01-25
    Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to misread the analog results shown on the pr…
  • Class IITerminated2013-06-11
    Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination.
  • Class IITerminated2011-12-22
    Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.

FDA inspections (4)

  • NAI2024-08-12
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2023-08-08
    No Action Indicated · Compliance: Devices
  • NAI2022-07-15
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2017-10-31
    Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Church & Dwight Manufacturing Co., Inc. (FEI 1122329) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1122329-church-dwight-manufacturing-co-inc/

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